ENALAPRIL 5 mg Tabletki Powlekane

Treść ulotki

1. Enalapril Aurobindo Pharma Italia 5 mg tablets, 20 mg tablets
   1. What is Enalapril Aurobindo Pharma Italia and what it is used for
   2. What you need to know before taking Enalapril Aurobindo Pharma Italia
   3. How to take Enalapril Aurobindo Pharma Italia
   4. Possible side effects
   5. How to store Enalapril Aurobindo Pharma Italia
   6. Contents of the pack and other information

Enalapril Aurobindo Pharma Italia 5 mg tablets, 20 mg tablets

Generic medicine
Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Enalapril Aurobindo Pharma Italia is and what it is used for
• 2. What you need to know before you take Enalapril Aurobindo Pharma Italia
• 3. How to take Enalapril Aurobindo Pharma Italia
• 4. Possible side effects
• 5. How to store Enalapril Aurobindo Pharma Italia
• 6. Contents of the pack and other information

1. What is Enalapril Aurobindo Pharma Italia and what it is used for

Enalapril Aurobindo Pharma Italia contains an active ingredient called enalapril maleate. This
active ingredient belongs to a group of medicines called ACE inhibitors (angiotensin converting enzyme
inhibitors).
Enalapril Aurobindo Pharma Italia is used:

• to treat high blood pressure (hypertension);
• to treat heart failure (weakening of the heart's function). It can reduce the need to go to hospital and can help some patients to live longer;
• to prevent the signs of heart failure. The signs include: shortness of breath, fatigue after light activity such as walking, or swelling of the ankles and feet.

This medicine works by widening your blood vessels. This lowers your blood pressure.
The medicine usually starts to work within one hour, and the effects last for at least 24 hours. Some
people will need several weeks of treatment before the best effect on blood pressure can be seen.

2. What you need to know before taking Enalapril Aurobindo Pharma Italia

Do not take Enalapril Aurobindo Pharma Italia

• if you are allergic to enalapril maleate or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously had an allergic reaction to a medicine of a type similar to this medicine called an ACE inhibitor;
• if you have previously experienced swelling of the face, lips, mouth, tongue or throat which caused difficulty in swallowing and breathing (angioedema) of unknown or hereditary origin;
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure containing aliskiren;
• if you are pregnant for more than 3 months (it is also preferable to avoid using Enalapril Aurobindo Pharma Italia in the early stages of pregnancy - see section Pregnancy);
• if you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat);
• if you are taking any of the following medicines, the risk of angioedema may be increased: o racecadotril, a medicine used to treat diarrhoea; o medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus); o vildagliptin, a medicine used to treat diabetes.

Do not take this medicine if you have any of the problems listed above. If you are not sure,
talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Enalapril Aurobindo Pharma Italia:

• if you have a heart problem;
• if you have a condition involving blood vessels in the brain;
• if you have a blood problem such as a low number or absence of white blood cells (neutropenia/agranulocytosis), a low number of platelets (thrombocytopenia) or a reduction in the number of red blood cells (anaemia);
• if you have a liver problem;
• if you have a kidney problem (including kidney transplant). This can lead to an increase in potassium levels in the blood which can be serious. Your doctor may need to adjust the dose of Enalapril Aurobindo Pharma Italia or monitor your blood potassium levels;
• if you are undergoing dialysis;
• if you have recently been very ill (excessive vomiting) or if you have had severe diarrhoea;
• if you are following a low-salt diet, taking potassium supplements, potassium-sparing agents, or salt substitutes containing potassium;
• if you are over 70 years of age;
• if you have diabetes. Careful monitoring is needed to see if your blood glucose levels fall, especially during the first month of treatment. Your potassium levels in the blood may also be higher;
• if you have had an allergic reaction in the past with swelling of the face, lips, tongue or throat with difficulty swallowing or breathing. You should know that black patients are at a higher risk for these types of reactions to ACE inhibitors;
• if you suffer from low blood pressure (which you may notice as feeling faint or dizzy, especially when standing up);
• if you have a collagen vascular disease (e.g. lupus erythematosus, rheumatoid arthritis or scleroderma), if you are having therapy that suppresses the immune system, if you are taking allopurinol or procainamide, or a combination of these;
• if you are taking an mTOR inhibitor (e.g. temsirolimus, sirolimus, everolimus: medicines used to treat some types of cancer or to prevent rejection of a transplanted organ by the body's immune system). You may have an increased risk of an allergic reaction called angioedema;
• if you are taking one of the following medicines used to treat high blood pressure: o an angiotensin II receptor blocker (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan, etc.), especially if you have kidney problems related to diabetes; o aliskiren.

Your doctor may check your kidney function, blood pressure and the amount of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is stated under “Do not take Enalapril Aurobindo Pharma Italia”.
You must tell your doctor if you think you may be (or could be) pregnant. This medicine is not
recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it can cause serious harm to the baby if used during that time (see
section Pregnancy).
You should know that in black patients this medicine reduces blood pressure less
effectively than in non-black patients.
If you are not sure whether any of the above conditions apply to you, talk to your doctor or
pharmacist before taking this medicine.

If you are going to have a procedure
If you are going to have any of the following procedures, tell your doctor that you are taking
Enalapril Aurobindo Pharma Italia:

• any type of surgery or anaesthesia (even from the dentist);
• a treatment to remove cholesterol from the blood called “LDL apheresis”;
• a desensitisation treatment, to reduce the effect of an allergy to bee or wasp stings.
• If any of the above applies to you, talk to your doctor or dentist before the procedure.

Other medicines and Enalapril Aurobindo Pharma Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This includes herbal medicines. This is because Enalapril
Aurobindo Pharma Italia can interfere with the way some medicines work. Also
some other medicines can interfere with the way Enalapril Aurobindo
Pharma Italia works. Your doctor may need to change your dose and/or take other
precautions.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• an angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is stated under “Do not take Enalapril Aurobindo Pharma Italia” and “Warnings and precautions”);
• other medicines to lower blood pressure, such as beta-blockers or diuretics;
• potassium supplements (including salt substitutes), potassium-sparing diuretics (such as spironolactone, triamterene or amiloride) and other medicines that may increase the amount of potassium in your blood (such as trimethoprim and co-trimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant medicine used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent blood clots);
• medicines for diabetes (including oral antidiabetics and insulin);
• lithium (a medicine used to treat a certain type of depression);
• medicines for depression called “tricyclic antidepressants”;
• medicines for mental problems called “antipsychotics”;
• some medicines for coughs and colds and medicines that reduce body weight that contain an agent called “sympathomimetic”;
• some medicines for pain or arthritis including therapy with gold salts;
• an mTOR inhibitor (e.g. temsirolimus, sirolimus, everolimus: medicines used to treat some types of cancer or to prevent rejection of a transplanted organ by the body's immune system). See also the information contained in the section “Warnings and precautions”;
• non-steroidal anti-inflammatory medicines, including COX-2 inhibitors (medicines that reduce inflammation, and which can be used to help relieve pain);
• aspirin (acetylsalicylic acid);
• medicines used to dissolve blood clots (thrombolytics);
• alcohol.

If you are not sure whether any of the above conditions apply to you, talk to your doctor or
pharmacist before taking this medicine.

Enalapril Aurobindo Pharma Italia with food and drink
Enalapril Aurobindo Pharma Italia can be taken with or without food. Most
people take Enalapril Aurobindo Pharma Italia with a glass of water.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, or suspect you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine. Usually your
doctor will advise you to stop taking Enalapril Aurobindo Pharma Italia before
pregnancy or as soon as you find out you are pregnant and will advise you to
take another medicine instead of Enalapril Aurobindo Pharma Italia. This medicine is not
recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it can cause serious harm to the baby if taken after the third month of
pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Breastfeeding of newborns
(first weeks after birth), especially premature babies, is not recommended during the use of
this medicine. In the case of an older child, your doctor will inform you about the benefits and
risks associated with taking this medicine during breastfeeding, compared to other
treatments.

Driving and using machines
While taking this medicine you may feel dizzy or sleepy. If this happens,
do not drive and do not use any tools or machines.

Enalapril Aurobindo Pharma Italia contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking
this medicine.

3. How to take Enalapril Aurobindo Pharma Italia

Take this medicine always exactly as your doctor or pharmacist has told you.
If you have any doubts, ask your doctor or pharmacist.

• It is very important to continue taking this medicine for as long as prescribed by your doctor.
• Do not take more tablets than prescribed.

High blood pressure

• The usual starting dose ranges from 5 to 20 mg once a day.
• Some patients may need a lower starting dose.
• The usual maintenance dose is 20 mg once a day.
• The maximum maintenance dose is 40 mg once a day.

Heart failure

• The usual starting dose is 2.5 mg once a day.
• Your doctor will gradually increase this amount until the right dose for you has been reached.
• The usual maintenance dose is 20 mg per day, taken in one or two doses.
• The maximum maintenance dose is 40 mg per day, divided into two doses.

Patients with kidney problems
The dose of the medicine will be modified based on how well your kidneys are working:

• Moderate kidney problems - 5 mg to 10 mg per day.
• Severe kidney problems - 2.5 mg per day.
• If you are undergoing dialysis - 2.5 mg per day. On the days you are not undergoing dialysis, the dose may be modified depending on how low your blood pressure is.

Elderly patients
The dose will be decided by your doctor and will be based on the degree of kidney function.

Use in children
Experience with the use of Enalapril Aurobindo Pharma Italia in children with high blood pressure
is limited. If the child is able to swallow the tablets, the dose will be established based on the child’s weight
and blood pressure. The usual starting doses are:

• Body weight between 20 kg and 50 kg - 2.5 mg per day.
• Body weight over 50 kg - 5 mg per day. The dose may be modified according to the child’s needs:
• A maximum dose of 20 mg per day may be used in children weighing between 20 kg and 50 kg.
• A maximum dose of 40 mg per day may be used in children weighing over 50 kg.

This medicine is not recommended in newborns (first weeks of life) and in children with
kidney problems.

If you take more Enalapril Aurobindo Pharma Italia than you should
If you take more Enalapril Aurobindo Pharma Italia than you should, tell your doctor or go
immediately to hospital. Bring the medicine pack with you. The following effects may occur: feeling dizzy or lightheaded. This is due to a sudden or
excessive decrease in blood pressure.

If you forget to take Enalapril Aurobindo Pharma Italia

• If you forget to take a tablet, skip the missed dose.
• Take the next dose as usual.
• Do not take a double dose to make up for a missed dose.

If you stop taking Enalapril Aurobindo Pharma Italia
Do not stop taking the medicine unless your doctor tells you to.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:

Stop taking Enalapril Aurobindo Pharma Italia and contact your doctor immediately if you notice any of the following:

• Swelling of the face, lips, tongue or throat that may cause difficulty breathing or swallowing.
• Swelling of the hands, feet or ankles.
• If you develop a skin rash with raised, red patches (urticaria). You should know that black patients are at an increased risk of developing these types of reactions. If any of the above occurs, stop taking Enalapril Aurobindo Pharma Italia and contact your doctor immediately.

When you start taking this medicine you may feel dizzy or lightheaded. If this happens, it may be helpful to lie down. This is caused by low blood pressure. It should improve as you continue to take the medicine. If you are concerned, contact your doctor.
Other side effects include:

Very common(may affect more than 1 in 10 people)

• Feeling dizzy, weak or unwell.
• Blurred vision.
• Cough.

Common(may affect up to 1 in 10 people)

• Dizziness due to low blood pressure, changes in heart rate, fast heartbeat, angina or chest pain.
• Headache, depression, fainting (syncope), altered sense of taste.
• Shortness of breath.
• Diarrhoea, abdominal pain.
• Fatigue (tiredness).
• Skin rash, allergic reactions with swelling of the face, lips, tongue or throat with difficulty breathing or swallowing.
• High levels of potassium in the blood, increased creatinine levels in the blood (both usually found with a laboratory test).

Uncommon(may affect up to 1 in 100 people)

• Flushing.
• Sudden drop in blood pressure.
• Fast or irregular heartbeat (palpitations).
• Heart attack (possibly due to very low blood pressure in some high-risk patients, including those with blood flow problems to the heart or brain).
• Stroke (possibly due to very low blood pressure in high-risk patients).
• Anaemia (including aplastic and haemolytic anaemia).
• Confusion, insomnia or drowsiness, nervousness.
• Pins and needles or numbness of the skin.
• Vertigo (a sensation of spinning).
• Ringing in the ears (tinnitus).
• Runny nose, sore throat or hoarseness.
• Tightness in the chest associated with asthma.
• Slowed movement of food through the intestine (ileus), inflammation of the pancreas.
• Feeling sick (vomiting), indigestion, constipation, loss of appetite.
• Irritated stomach (gastric irritation), dry mouth, ulcer.
• Muscle cramps.
• Impaired kidney function, kidney failure.
• Increased sweating.
• Itching or urticaria.
• Hair loss.
• General feeling of being unwell (malaise), high temperature (fever).
• Impotence.
• High level of protein in the urine (measured with a laboratory test).
• Low level of sugar or sodium in the blood, high level of urea in the blood (all measured with a blood test).

Rare(may affect up to 1 in 1,000 people)

• “Raynaud’s phenomenon” where fingers and toes can become very cold and white due to poor blood flow.
• Changes in blood values such as decreased number of white blood cells and red blood cells, decreased haemoglobin, decreased number of platelets.
• Bone marrow suppression.
• Swelling of the glands in the neck, armpits or groin.
• Autoimmune diseases.
• Strange dreams or sleep disturbances.
• Accumulation of fluid or other substances in the lungs (seen on an X-ray).
• Inflammation of the nose.
• Inflammation of the lungs causing difficulty breathing (pneumonitis).
• Inflammation of cheeks, gums, tongue, lips, throat.
• Decreased amount of urine.
• Skin rash similar to a target (erythema multiforme).
• “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (serious skin conditions involving redness and blistering or exposed skin, blistering or ulceration), exfoliative dermatitis/erythroderma (severe skin rash with scaling or shedding of the skin), pemphigus (small blisters filled with fluid on the skin).
• Liver or gallbladder problems such as reduced liver function, inflammation of the liver, jaundice (yellowing of the skin or eyes), high levels of liver enzymes or bilirubin (measured with a blood test).
• Breast enlargement in men (gynaecomastia).

Very rare(may affect up to 1 in 10,000 people)

• Swelling in the intestine (intestinal angioedema).

Not known(frequency cannot be estimated from the available data)

• Overproduction of antidiuretic hormone, which causes fluid retention, leading to weakness, fatigue or confusion.
• A complex of symptoms has been reported that may include some or all of the following events: fever, inflammation of blood vessels (serositis/vasculitis), muscle pain (myalgia/myositis), joint pain (arthralgia/arthritis). Skin rash, photosensitivity or other skin manifestations may occur.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Enalapril Aurobindo Pharma Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the package after
the words “Exp.”. The expiry date refers to the last day of that month.
Store at a temperature below 30°C.
Do not dispose of this medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Enalapril Aurobindo Pharma Italia contains

• The active ingredient is enalapril maleate. Each tablet contains 5 mg of enalapril maleate.

Each tablet contains 20 mg of enalapril maleate.

• The other ingredients are lactose monohydrate, pregelatinized starch (corn starch), glycerol distearate (Type I).

Description of the appearance of Enalapril Aurobindo Pharma Italia and contents of the pack

Enalapril Aurobindo Pharma Italia 5 mg tablets
Uncoated tablets, of a colour from white to off-white, round (diameter 5 mm), flat with
bevelled edges, with imprinted “E” and “5” separated by a break line on one side and smooth on the
other side. The tablet can be divided into equal doses.

Enalapril Aurobindo Pharma Italia 20 mg tablets
Uncoated tablets, of a colour from white to off-white, round (diameter 8.5 mm), flat with
bevelled edges, with imprinted “2” and ”0” separated by a break line on one side and “E” on the
other side. The tablet can be divided into equal doses.
Enalapril Aurobindo Pharma Italia 5 mg and 20 mg tablets is available in triple laminated aluminium (Alu-Alu) and transparent PVC-Al blisters.
Pack sizes:
Blister packs:
5 mg: 10, 20, 28, 30, 50, 60, 84, 90 and 100 tablets.
20 mg: 14, 28, 30, 50, 84, 90 and 100 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102

• 21047 - Saronno (VA)

Manufacturers:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate
Hal Far, Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
France: Enalapril Arrow Lab 5 mg/20 mg divisible tablet
Germany: Enalapril PUREN 2.5 mg/5 mg/10 mg/20 mg Tablets
Italy: Enalapril Aurobindo Pharma Italia
Netherlands: Enalaprilmaleaat Aurobindo 2.5 mg/5 mg/10 mg/20 mg, tablets
Portugal: Enalapril Generis Phar
Spain: Enalapril Aurovitas 5 mg film-coated tablets EFG
Enalapril Aurovitas 10 mg film-coated tablets
Enalapril Aurovitas 20 mg film-coated tablets EFG